Bsi bs en 60601 2 33 2010 + a2 2015

BS EN 60601-2-33:2010+A21:2015 Incorporating corrigendum October 2010 BSI Standards Publication Medical electrical equipment Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis BS EN 60601-2-33:2010+A2:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 60601-2-33:2010+A2:2015, incorporating corrigendum October 2010 It is identical to IEC 60601-2-33:2010, incorporating amendment 1:2013 and amendment 2:2015 It supersedes BS EN 60601-2-33:2010+A1:2015, which will be withdrawn on 23 July 2018 The start and finish of text introduced or altered by corrigendum is indicated in the text by tags Tags altered by CENELEC corrigendum November 2010 is indicated in the text by  The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to IEC text carry the number of the IEC amendment For example, text altered by IEC amendment is indicated by  BSI, as a member of CENELEC, is obliged to publish EN 60601-2-33 as a British Standard However, attention is drawn to the fact that during the development of this European Standard, the UK committee voted against its approval as a European Standard The UK Committee believes that the change in the instructions for use for scanning pregnant patients (in Subclause 201.7.9.2.101 u) should include the recommendation to limit rises in body temperature to less than 0,5°C, as is recommended in Annex AA The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipment A list of organizations represented on this subcommittee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 87170 ICS 11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2010 Amendments/corrigenda issued since publication Date Text affected 31 March 2011 Implementation of CENELEC corrigendum October 2010; Annex ZZ revised 30 April 2012 Implementation of CENELEC amendment A11:2011: Annex ZZ revised 31 July 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015 Annex ZA updated Implementation of IEC amendment 2:2015 with CENELEC endorsement A2:2015 Annex ZA updated EUROPEAN STANDARD EN 60601-2-33:2010+A121 NORME EUROPÉENNE EUROPÄISCHE NORM MSOeapcyteo2mb0e1br5e2r 0210115 ICS 11.040.55 Incorporating corrigendum October 2010 Supersedes EN 60601-2-33:2010 English version Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010) Appareils électromédicaux - Medizinische elektrische Geräte - Partie 2-33: Exigences particulières pour Teil 2-33: Besondere Festlegungen für die la sécurité de base et les performances Sicherheit von Magnetresonanzgeräten essentielles des appareils résonance für die medizinische Diagnostik magnétique utilisés pour le diagnostic (IEC 60601-2-33:2010) médical (CEI 60601-2-33:2010) This European Standard was approved by CENELEC on 2010-10-01 CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels © 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members Ref No EN 60601-2-33:2010 E BS EN 60601-2-33:2010+A21:2015 – – EN 60601-2-33:2010+A21:2015 (E) – – BS EN 60601-2-33:2010+A11:2011 EN 60601-2-33:2010+A11:2011 (E) Foreword The text of document 62B/777/FDIS, future edition of IEC 60601-2-33, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-33 on 2010-10-01 This European Standard supersedes EN 60601-2-33:2002 + A1:2005 + A2:2008 This EN 60601-2-33:2010 is based on the second amendment to EN 60601-2-33:2002 It has also been adapted to EN 60601-1:2006, with technical modifications being introduced where appropriate The contents of the corrigendum of October 2010 have been included in this copy Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN and CENELEC shall not be held responsible for identifying any or all such patent rights The following dates were fixed: – latest date by which the EN has to be implemented (dop) 2011-07-01 at national level by publication of an identical (dow) 2013-10-01 national standard or by endorsement – latest date by which the national standards conflicting with the EN have to be withdrawn In this standard, the following print types are used: – Requirements and definitions: roman type – Test specifications: italic type – Informative material appearing outside of tables, such as notes, examples and references: in smaller type Normative text of tables is also in a smaller type – TERMS DEFINED IN CLAUSE OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g Clause includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7) References to clauses within this standard are preceded by the term “Clause” followed by the clause number References to subclauses within this particular standard are by number only In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part For the purposes of this standard, the auxiliary verb: – “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; – “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; – “may” is used to describe a permissible way to achieve compliance with a requirement or test An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA – – BS EN 60601-2-33:2010+A12:2015 – – EN 60601-2-33:2010+A12:2015 (E) BS EN 60601-2-33:2010+A11:2011 EN 60601-2-33:2010+A11:2011 (E) This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC See Annex ZZ Annexes ZA and ZZ have been added by CENELEC Endorsement notice The text of the International Standard IEC 60601-2-33:2010 was approved by CENELEC as a European Standard without any modification Foreword to amendment A11 This document (EN 60601-2-33:2010/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice” The following dates are fixed: • latest date by which this document has (dop) 2012-10-01 to be implemented at national level by publication of an identical national standard or by endorsement • latest date by which the national (dow) 2014-10-01 standards conflicting with this document have to be withdrawn Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights BBSS EENN 6600660011 22 3333::22001100++AA21::22001155 –– 44 –– EENN 6600660011 22 3333::22001100++AA21::22001155 ((EE)) EN 60601-2-33:2010/A1:2015 ForewordFtooreawmoernddment A1 The text of document 62B/884/CDV, future IEC 60601-2-33:2010/A1, prepared by SC 62B "Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-33:2010/A1:2015 The following dates are fixed: • latest date by which the document has to be (dop) 2016-01-14 implemented at national level by (dow) 2018-04-14 publication of an identical national standard or by endorsement • latest date by which the national standards conflicting with the document have to be withdrawn Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-33:2010/A11:2011 Endorsement notice The text of the International Standard IEC 60601-2-33:2010/A1:2013 was approved by CENELEC as a European Standard without any modification In the Bibliography of EN 60601-2-33:2010, the following note has to be added for the standard indicated: ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012 (not modified) – – BS EN 60601-2-33:2010+A2:2015 EN 60601-2-33:2010+A2:2015 (E) EN 60601-2-33:2010/A2:2015 European foreword Foreword to amendment A2 The text of document 62B/977/FDIS, future IEC 60601-2-33:2010/A2 prepared by SC 62B "Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-33:2010/A2:2015 The following dates are fixed: • latest date by which the document has to be (dop) 2016-04-23 implemented at national level by (dow) 2018-07-23 publication of an identical national standard or by endorsement • latest date by which the national standards conflicting with the document have to be withdrawn Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-33:2010/A11:2011 Endorsement notice The text of the International Standard IEC 60601-2-33:2010/A2:2015 was approved by CENELEC as a European Standard without any modification In the Bibliography of EN 60601-2-33:2010, the following note has to be added for the standard indicated: IEC 62570:2014 NOTE Harmonized as EN 62570:2015 (not modified) BS EN 60601-2-33:2010+A2:2015 – 56 – BS EN 60601-2-33:2010+A1:2015 EN 60601-2-33:2010+A2:2015 (E) – – EN 60601-2-33:2010+A1:2015 (E) BS EN 60601-2-33:2010+A11:2011 – – EBNS E60N660016-20-13-32:-23031:200+1A01+1A:21011:210(1E1) EN 60601-2-33:2010+A11:2011 (E) BS EN 60601-2-33:2010+A11:2011 Annex ZA ENE6N0660016-021-3-23-:3230:1200/1A01/:A210:125015 EN 60601-2-33:2010+A11:2011 (E) (An–onr4nme–axtiZvAe) A(nnAonrnemnxaeZtxiAvZeA) Normative referenc(enAso(rnntmoonraeimntxivatZeetir)Avnea)tional publications ENE6N0660016-021-3-23-:3230:1200/1A01/:A210:125015 Nworitmhatthiveeir 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RepRleapcleactheetheexiesxtiinsgtinregferers-sddeftyeiCeansvongrtcieecldnlemaenaotsrsctesdtorei:icanENltmmoSlEeatecNMagtdnrnEAiodceMmaatMilrcaAdeSgr:leenMG4sceSeot:tri2ncic40eaca:0rno2lac6em0leq0bpui6mayiptaibtbmhgyileieinttnyghfto-e(MllfoRo+wIAl)loi1n/wAgiC:ng: 2008 arCRdeneheqdvaquirucmiareiercesemtdemierceinazntalstets,iolteaencnstodtrsfictteaahsnletdsssygpsuteeicdmiafisnccaebfsoorrpatlaiornm - 2014 NEMA MS - NEMNEAMMASM48S 2200102068010 sACraychtsoeatAuer(casmSoctAisutceRsinrnti)iozcmfaiosntreeiodmimnsicaeoeagfamlntseheeuleetaricesstmurpeirceesacnmolitfneeipcaqnrnaoutcbcpipeesrmodimcruepernateditgoufinnoregr -for- adsrayniatsdegdtenm(iaSmoegsAsdntRiiocc)saMmtfliocaerglMemncaeatgrtgiinccneaeRrtletiicescssyoRrsoneetnaessaonmonncnsceaaennimcIcmeeaagiImgminiangaggg(iniMnggRI) - (dsMyesvR(tieMcI)emRdsseI)vdiceevsices NEMA MS 2008 Characterization of the specific absorption - - rate (SAR) for magnetic resonance imaging systems BS EN 60601-2-33:2010+A1:2015 – 6––7 – BS EN 60601-2-33:2010+A2:2015 EN 60601-2-33:2010+A1:2015 (E) – – EN 60601-2-33:2010+A2:2015 (E) BS EN 60601-2-33:2010+A11:2011 EN 60601-2-33:2010+A11:2011 (E) Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC except as follows: – Essential Requirement 6a – Essential Requirement 7.4 – Essential Requirement 7.5 paragraph & – Essential Requirement 13.6 (q) Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard BS EN 60601-2-33:2010+A2:2015 – – IEC 60601-2-33:2010+A2:2015 CONTENTS INTRODUCTION������������������������������������������������������������������������������������������������������������������� 10 201.1 Scope, object and related standards���������������������������������������������������������������������� 11 201.2 Normative references��������������������������������������������������������������������������������������������12 201.3 Terms and definitions��������������������������������������������������������������������������������������������� 13 201.4 General requirements��������������������������������������������������������������������������������������������19 201.5 General requirements for testing of me equipment��������������������������������������������������19 201.6 Classification of me equipment and me systems������������������������������������������������������20 201.7 Me equipment identification, marking and documents���������������������������������������������20 201.8 Protection against electrical hazards from me equipment���������������������������������������� 33 201.9 Protection against mechanical hazards of me equipment and me systems��������������� 33 201.10 Protection against unwanted and excessive radiation hazards�������������������������������34 201.11 Protection against excessive temperatures and other hazards������������������������������� 34 201.12 Accuracy of controls and instruments and protection against hazardous outputs������� 34 201.13 Hazardous situations and fault conditions������������������������������������������������������������ 55 201.14 Programmable electrical medical system (pems)�������������������������������������������������55 201.15 Construction of me equipment��������������������������������������������������������������������������������55 201.16 Me systems�����������������������������������������������������������������������������������������������������������55 201.17 Electromagnetic compatibility of me equipment and me systems�����������������������������56 202 Electromagnetic compatibility – Requirements and tests����������������������������������������56 Annexes������������������������������������������������������������������������������������������������������������������������������� 57 Annex D (informative)  Symbols on marking��������������������������������������������������������������������������� 58 Annex AA (informative)  Particular guidance and rationale�����������������������������������������������������62 Bibliography������������������������������������������������������������������������������������������������������������������������ 115 Index of defined terms used in this particular standard�������������������������������������������������������� 126 Figure 201.101 – Gradient waveform and effective stimulus duration��������������������������������� 14 Figure 201.102 – Limits for cardiac and peripheral nerve stimulation�������������������������������������39 Figure 201.103 – Reduction of whole body sar limits at high temperatures���������������������������43 Figure 201.104 – Volume for determining the spatial maximum of gradient output������������������ 49 Figure 201.105 – Volume for determining the B1 stray field���������������������������������������������������� 52 Figure AA.1 – Static magnetic fields: flow potentials and retardation��������������������������������������85 Figure AA.2 – Experimental data on PNS threshold of human volunteers in whole body mr equipment���������������������������������������������������������������������������������������������������������������������� 100 Figure AA.3 – Double logarithmic plot of experimental threshold values for peripheral nerve stimulation���������������������������������������������������������������������������������������������������������������� 101 Figure AA.4 – Response value R(t) generated by convolution of a rectangular stimulus dB/dt and a nerve impulse response function n(t-θ)����������������������������������������������� 105 Figure AA.5 – Gradient waveform G, stimulus waveform dB/dt and response value R, for a trapezoid EPI waveform starting at t = 0���������������������������������������������������������������������� 106 Figure AA.6 – Threshold values dB/dt for two gradient waveforms, plotted against effective stimulus duration����������������������������������������������������������������������������������������������� 106 Figure AA.7 – Threshold value of dB/dt for a sinusoid gradient waveform, as function of the number of half periods in the waveform��������������������������������������������������������������������� 107 Figure AA.8 – sar limits for the exposed mass of a patient�������������������������������������������������� 110